A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors

NCT04467853 | Terminated Phase 1

• 1 other identifier: BM2L201910
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors.

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety

  Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety

  Minimum 2 years after LCAR-C18S infusion (Day 1)

• To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)

  To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)

  90 days post infusion

• Pharmacokinetic (PK) parameters

  Blood samples will be collected for determination of cellular concentrations and transgenic levels of serum LCAR-C18S for pharmacokinetic analysis

  Minimum 2 years after LCAR-C18S infusion (Day 1)

Secondary Outcomes (3)

• Overall response rate (ORR) after administration

  Minimum 2 years after LCAR-C18S infusion (Day 1)

• Progress Free Survival (PFS) after administration

  Minimum 2 years after LCAR-C18S infusion (Day 1)

• Overall Survival (OS) after administration

  Minimum 2 years after LCAR-C18S infusion (Day 1)

Study Arms (1)

LCAR-C18S Cells

EXPERIMENTAL

Each subject will receive LCAR-C18S Cells

Biological: LCAR-C18S cells

Interventions

LCAR-C18S cells BIOLOGICAL

Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen

LCAR-C18S Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form;
• Age 18-70 years;
• Immunohistochemistry of tumor tissue samples indicates Claudin18.2 positive ;
• Recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment
• According to the RECIST v1.1, at least one measuable tumor lesion;
• ECOG performance status score of 0-1;
• Expected survival ≥ 3 months;
• Subjects should have adequate organ functions before screening and treatment.
• Women of childbearing age must have a negative blood pregnancy test; subjects of childbearing potential must use effective contraception for ≥ 1 year after the final study treatment.

You may not qualify if:

• Previous CAR-T cell therapy or other cell therapies or therapeutic tumor vaccination against any target;
• Any previous therapy targeting Claudin18.2;
• Prior antitumor therapy with insufficient washout period;
• Pregnant or lactating women;
• Brain metastases with central nervous system symptoms;
• Uncontrolled diabetes;
• Oxygen is required to maintain adequate blood oxygen saturation;
• Gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention;
• Clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis);
• HIV, Treponema pallidum or HCV serologically positive;
• Severe underlying disease
• New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 50%; unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) in the past 6 months; history of severe non-ischemic cardiomyopathy; or severe uncontrolled arrhythmia;
• Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (3)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Shanghai East Hospital

Shanghai, China/Shanghai, 200126, China

Location

Shanghai Artemed Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jin Li, MD, PhD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 13, 2020
• Study Start: September 21, 2020
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)